CN101022831A - 稳定制剂 - Google Patents

稳定制剂 Download PDF

Info

Publication number
CN101022831A
CN101022831A CNA2005800274833A CN200580027483A CN101022831A CN 101022831 A CN101022831 A CN 101022831A CN A2005800274833 A CNA2005800274833 A CN A2005800274833A CN 200580027483 A CN200580027483 A CN 200580027483A CN 101022831 A CN101022831 A CN 101022831A
Authority
CN
China
Prior art keywords
protein
formulation
molecular weight
antibody
stability
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2005800274833A
Other languages
English (en)
Chinese (zh)
Inventor
L·李
A·坎托尔
S·B·麦米兰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth LLC
Original Assignee
Wyeth LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wyeth LLC filed Critical Wyeth LLC
Publication of CN101022831A publication Critical patent/CN101022831A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
CNA2005800274833A 2004-08-13 2005-08-12 稳定制剂 Pending CN101022831A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US60/601,311 2004-08-13

Publications (1)

Publication Number Publication Date
CN101022831A true CN101022831A (zh) 2007-08-22

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
CNA2005800274833A Pending CN101022831A (zh) 2004-08-13 2005-08-12 稳定制剂

Country Status (18)

Country Link
US (1) US8871201B2 (https=)
EP (1) EP1784219B1 (https=)
JP (1) JP4948407B2 (https=)
KR (1) KR20070092197A (https=)
CN (1) CN101022831A (https=)
AR (1) AR051009A1 (https=)
AU (1) AU2005272603A1 (https=)
BR (1) BRPI0514340A (https=)
CA (1) CA2575870A1 (https=)
CR (1) CR8904A (https=)
EC (1) ECSP077246A (https=)
ES (1) ES2637854T3 (https=)
IL (1) IL181265A0 (https=)
MX (1) MX2007001599A (https=)
NO (1) NO20070930L (https=)
RU (1) RU2007109062A (https=)
TW (1) TW200621282A (https=)
WO (1) WO2006020935A2 (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109661577A (zh) * 2016-08-18 2019-04-19 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CN115541895A (zh) * 2022-11-29 2022-12-30 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
MX2007015476A (es) 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
JP2009534390A (ja) * 2006-04-21 2009-09-24 アムジェン インコーポレイテッド 生物医薬品製剤のための緩衝剤
MX2008013508A (es) * 2006-04-21 2008-10-31 Novartis Ag Composiciones farmaceuticas de anticuerpos antagonistas anti-cd40.
US20080070230A1 (en) * 2006-06-12 2008-03-20 Wyeth Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions
EP1950225A1 (de) * 2007-01-25 2008-07-30 Octapharma AG Verfahren zur Steigerung von Proteinausbeuten
CA2681752A1 (en) * 2007-03-29 2008-10-09 Abbott Laboratories Crystalline anti-human 1l-12 antibodies
TWI543768B (zh) * 2007-11-30 2016-08-01 艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
WO2010062896A1 (en) * 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
WO2011026948A1 (en) 2009-09-03 2011-03-10 Ablynx N.V. Stable formulations of polypeptides and uses thereof
WO2010100135A1 (en) 2009-03-05 2010-09-10 Ablynx N.V. Novel antigen binding dimer-complexes, methods of making/avoiding and uses thereof
MX2011011772A (es) * 2009-05-04 2012-02-08 Abbott Biotech Ltd Formulaicones estables de anticuerpos humanos anti-tnf-alfa con alta concentracion de proteina.
CN113244374A (zh) * 2011-07-01 2021-08-13 生物基因Ma公司 无精氨酸的tnfr:fc-融合多肽组合物及使用方法
EP2785406A4 (en) 2011-11-30 2015-10-21 3M Innovative Properties Co MICRONADEL DEVICE WITH A PEPTIDE THERAPEUTIC AND AN AMINO ACID AND METHOD FOR THE PRODUCTION AND USE THEREOF
JP6265970B2 (ja) * 2012-03-26 2018-01-24 サノフイ 安定なＩｇＧ４に基づく結合剤の製剤
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US9844594B2 (en) * 2012-12-18 2017-12-19 Merck Sharp & Dohme Corp. Liquid formulations for an anti-TNF α antibody
CN105828841A (zh) 2013-11-04 2016-08-03 辉瑞大药厂 抗-efna4抗体-药物缀合物
FI3834824T3 (fi) 2014-03-28 2025-12-05 Univ Duke Estrogeenireseptoripositiivisen rintasyövän hoito selektiivisellä estrogeenireseptorin modulaattorilla
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
JP7019422B2 (ja) 2015-04-29 2022-02-15 ラジウス ファーマシューティカルズ，インコーポレイテッド 癌を治療するための方法
GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
KR102707399B1 (ko) 2017-01-05 2024-09-13 래디어스 파마슈티컬스, 인코포레이티드 Rad1901-2hcl의 다형 형태
IL279853B2 (en) 2018-07-04 2025-01-01 Radius Pharmaceuticals Inc Polymorphic forms of RAD 1901-2HCL
CN113348163B (zh) 2019-02-12 2024-10-08 雷迪厄斯制药公司 方法和化合物
EP4142792A4 (en) * 2020-05-01 2024-11-27 Kashiv Biosciences, LLC An improved process of purification of protein
US20240059768A1 (en) * 2021-01-14 2024-02-22 Hanall Biopharma Co., Ltd. A stable ophthalmic composition comprising tanfanercept, which is free of stabilizer or substantially free of stabilizer

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3176517D1 (en) * 1980-04-24 1987-12-17 Beecham Group Plc Beta-lactam compounds, their preparation and use
GB8518416D0 (en) 1985-07-22 1985-08-29 Beecham Group Plc Compounds
US5869053A (en) * 1988-03-04 1999-02-09 Cancer Research Campaign Technology, Ltd. 5T4 antigen from human trophoblasts
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6306393B1 (en) * 1997-03-24 2001-10-23 Immunomedics, Inc. Immunotherapy of B-cell malignancies using anti-CD22 antibodies
EP1717248A1 (en) * 1997-06-04 2006-11-02 Oxford Biomedica (UK) Limited Tumor targeted vector
EP0999853B1 (en) 1997-06-13 2003-01-02 Genentech, Inc. Stabilized antibody formulation
AU2444899A (en) 1998-01-22 1999-08-09 Astrazeneca Ab Pharmaceutical formulation comprising an antibody and a citrate buffer
JP4516711B2 (ja) * 1999-12-28 2010-08-04 中外製薬株式会社 安定な抗体組成物及び注射製剤
US8632778B2 (en) * 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
AU2003201824A1 (en) * 2002-01-03 2003-07-24 Smithkline Beecham Corporation Methods for preparing immunoconjugates
SI2371392T1 (sl) * 2002-05-02 2015-10-30 Wyeth Holdings Llc Konjugati derivat-nosilec kaliheamicina
WO2004001007A2 (en) * 2002-06-21 2003-12-31 Idec Pharmaceuticals Corporation Buffered formulations for concentrating antibodies and methods of use thereof
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
CA2535804A1 (en) * 2003-08-14 2005-03-03 Wyeth Anti-lewis y anti-idiotypic antibodies and uses thereof
PE20100251A1 (es) * 2004-09-10 2010-04-10 Wyeth Corp Anticuerpos anti-5t4 humanizados y conjugados anticuerpo anti-5t4/calicheamicina

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CN109661577A (zh) * 2016-08-18 2019-04-19 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
US11428695B2 (en) 2016-08-18 2022-08-30 Regeneron Pharmaceuticals, Inc. Concentration-dependent self-interaction assay
CN109661577B (zh) * 2016-08-18 2022-09-27 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
US11988668B2 (en) 2016-08-18 2024-05-21 Regeneron Pharmaceuticals, Inc. Concentration-dependent self-interaction assay
CN115541895A (zh) * 2022-11-29 2022-12-30 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

Also Published As

Publication number Publication date
MX2007001599A (es) 2007-04-10
JP2008515775A (ja) 2008-05-15
ES2637854T3 (es) 2017-10-17
WO2006020935A2 (en) 2006-02-23
TW200621282A (en) 2006-07-01
BRPI0514340A (pt) 2008-06-10
ECSP077246A (es) 2007-05-30
CA2575870A1 (en) 2006-02-23
EP1784219A2 (en) 2007-05-16
KR20070092197A (ko) 2007-09-12
EP1784219B1 (en) 2017-05-17
JP4948407B2 (ja) 2012-06-06
EP1784219A4 (en) 2010-02-17
US8871201B2 (en) 2014-10-28
AU2005272603A1 (en) 2006-02-23
NO20070930L (no) 2007-05-14
AR051009A1 (es) 2006-12-13
RU2007109062A (ru) 2008-09-20
IL181265A0 (en) 2007-07-04
CR8904A (es) 2007-08-28
US20060115472A1 (en) 2006-06-01
WO2006020935A3 (en) 2007-03-08

Similar Documents

Publication Publication Date Title
US8871201B2 (en) Stabilizing formulations
CN100353997C (zh) 稳定的含蛋白质的制剂
JP6496050B2 (ja) タンパク質が結合した作用物質化合物のインタクト質量の測定
CN101721362B (zh) 包含抗体的溶液制剂
ES2349779T5 (es) Formulaciones de anticuerpos y de proteínas a concentración elevada
KR20180100439A (ko) 이중특이적 항체 작제물을 포함하는 약제학적 조성물
US20150132320A1 (en) MUTATED ANTI-TNFa ANTIBODIES AND METHODS OF THEIR USE
JPWO2005063291A1 (ja) 抗体を含有する安定な水性医薬製剤
CN115485562A (zh) 减少药物调配物中聚山梨醇酯降解的方法
JP2017502085A (ja) Ｃｙｓ連結された抗体−薬物コンジュゲートの精製方法
JP2023506629A (ja) 安定した抗ｐｄ－１抗体の薬剤学的製剤
CN116234576A (zh) 抗-连接蛋白抗体制剂
JP2023512961A (ja) 安定した抗ｐｄ－１抗体薬剤学的製剤
JPWO2008029908A1 (ja) 抗体を含有する安定な凍結乾燥医薬製剤
CN114504642B (zh) 一种含抗cldn18.2抗体的液体药物组合物
CN117642180A (zh) 用于治疗炎性疾病和自身免疫性疾病的离子液体制剂
EP4255479A1 (en) Novel formulations for antibodies
ES2377125T3 (es) Procedimiento de purificación de proteínas
WO2021254447A1 (zh) 一种重组抗pd-1单克隆抗体的稳定制剂
JP2025023952A (ja) 液体タンパク質製剤を安定化するための組成物及び方法
US20190160177A1 (en) Method for increasing the bioavailability of inhaled compounds
JP2022531331A (ja) 抗ｉｌ－６抗体製剤
AU2020373017B2 (en) Crizanlizumab containing antibody formulation
CN118450906A (zh) 补体因子i制剂
CN117561079A (zh) 抗pd1抗体的制剂

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication

Open date: 20070822